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The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment

NCT01162330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2015-10-12

No results posted yet for this study

Summary

This study will look at the feasibility and acceptability of testing newborn babies who are referred after their newborn hearing screen for an infection called congenital Cytomegalovirus (cCMV). Around 1 in every 100 to 200 babies is born with this virus, and although most remain well it causes 1 in 5 cases of childhood deafness. Knowing that a baby is infected shortly after birth could have significant benefit since a treatment is now available, but screening programs need to be feasible and acceptable. This study aims to evaluate targeted screening for cCMV by taking samples (saliva and urine) from babies who do not pass their newborn hearing screening. The investigators want to see if we can find a quick, reliable and parentally acceptable way to screen babies who fail their hearing test for this virus.

Conditions

Interventions

OTHER

Screening urine and saliva tests for congenital Cytomegalovirus

With consent for the study babies who are referred for further hearing tests will have a urine and saliva sample sent to be analysed for CMV infection

Sponsors & Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Julia Clark · Newcastle-upon-Tyne Hospitals NHS Trust

  • Janet Berrington · Newcastle-upon-Tyne Hospitals NHS Trust

  • Mike Sharland · St Georges Healthcare Trust

  • Suzanne Luck · Royal Free Hospital NHS Foundation Trust

Eligibility

Max Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01162330 on ClinicalTrials.gov